A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Shanghai Junshi Bioscience Co., Ltd.48 sites in 1 country663 target enrollmentJune 23, 2021

ConditionsResectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Enrollment: 663
Locations: 48
Primary Endpoint: To compare IRC-assessed events-free survival (EFS) in 2 arms
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.

Registry

clinicaltrials.gov

Start Date

June 23, 2021

End Date

May 12, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

To compare IRC-assessed events-free survival (EFS) in 2 arms

Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months

Secondary Outcomes

1-year OS rate(from randomization to death from any cause at 1 year)
3- year OS rate(from randomization to death from any cause at 3 year)
5- year OS rate(from randomization to death from any cause at 5 year)
pathologically complete remission (pCR) rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
Investigator-assessed EFS according to RECIST v1.1(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
Overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)